As is known, the term “surgical suture” identifies a set of surgical procedures of various types, all of which are aimed at the stable bringing together of the two flaps of a wound, or in any case of two previously-cut flaps of body tissue, in order to favor their healing Such sets of procedures likewise includes those whose purpose is to fix prosthetic material of various types (e.g., vascular or valvular) to body tissues, for the substitution or reinforcement of natural structures with prosthetic material.
Although recently various alternative methods have been developed of carrying out such sutures (such as, for example, those involving the use of adhesives or plasters) in one of the most widespread techniques, the medical personnel passes one or more threads (usually made of polymeric material) through the flaps of tissue (body or prosthetic) to be brought together, in order to then form surgical knots and stitches, which keep the flaps in the desired position (brought together) during the healing process.
Moreover, for fixing suturable prosthetic materials to the natural tissues of the patient, the use of sutures of the type described above is made mandatory by the reference standards, and thus it cannot be substituted with one of the other methods cited.
In this regard, it should be noted that a first macro categorization of sutures makes a distinction between “continuous” sutures, in which the same thread is used in all the stitches without interruption, and “interrupted” sutures, in which the thread is cut after each stitch, or different threads are used, each of which goes to form a respective stitch.
It is the “interrupted” sutures which are used most frequently in cardiac surgery and thoracotomy operations, when what is necessary is reconstruction, anastomosis, or the fixing of prosthetic material to blood vessels or to intracardiac structures such as, for example, natural valve rings.
In such circumstances therefore, the surgeon first of all inserts, in sequence, a series of threads along the tissues (natural or prosthetic) to be joined, passing through the flaps at stitches which are conveniently spaced apart, so as to ensure an optimal join and without causing excessive trauma to the tissues.
In a second step, the surgeon (or other technician) grasps the mutually opposite ends of each thread, linking them and tying one or more respective knots (generally five or six): the repetition of such operation, for each thread, makes it possible to bring together the flaps, or fix the flaps to the prosthetic material, progressively and stably.
It thus appears evident that if the number of threads used is high, as sometimes happens, at the end of the first step the surgeon will be faced with a complex weave of threads, which have been inserted in the tissues but have not yet been knotted.
Therefore the risk is high of making mistakes during the tying of the knots, for example by inadvertently grasping the ends of two different threads, with evident negative consequences for the successful outcome of the suture (and of the subsequent healing) Furthermore, more generally, it seems evident that it is a very delicate and complex step to keep track of all the different threads simultaneously, without inadvertently tangling them together or in any case managing to work on the right thread without knocking, moving or damaging the other threads.
In order to overcome these drawbacks, use is made of an adapted instrument, called a “suture organizer”, which can be arranged in advance around to the wound (e.g., by resting the instrument on the chest of the patient) and which provide the surgeon with a useful guide, during the step of knotting each thread.
Such instruments are in fact constituted by rigid battens, rectangular or curved in plan view, which are placed on the chest of the patient so as to surround at least partially the wound to be sutured.
Above, each batten is provided with a plurality of protrusions arranged in series, arranged between which are blocks made of elastomeric material, so that, laterally, each block is in contact with the walls of the adjacent protrusions.
In each gap defined between contiguous blocks and protrusions it is thus possible to forcibly insert a respective end of a thread, thus ensuring the temporary anchoring thereof to the batten.
Each block (and/or each protrusion) further has an identification code (composed of numbers and/or letters): the surgeon, while inserting each thread into the flaps of tissue, can accommodate the respective ends of that thread on mutually opposite battens, at blocks that have the same code.
Thus, during the subsequent knotting, and after having grasped one end of the thread, the surgeon can immediately identify the other end, even in the tangle of threads that has been created, simply by selecting the end that is anchored to the block that has the same code.
Such implementation solution is not however devoid of drawbacks.
In fact, often the shape and the size of the wound to be sutured, as well as the specific surgical requirements which arise in each instance, are found to be unsuitable for the shape structure of the set of battens that the surgeon has available. If the battens do not adapt (in shape and size) to the structure and to the shape of the wound, then the accommodation of the ends of the thread at the blocks can be inconvenient, to the point that they complicate the suturing activity instead of simplifying it, and/or they impose incorrect paths on the various threads, which are dictated by the incorrect placement of the battens.
Moreover, it is precisely the difficulty of using the instruments described above, for injuries of shape and size which depart appreciably from those that usually need to be sutured in cardiac surgery or thoracotomy operations, that makes the method described above utterly impracticable for very small injuries, such as in mini-thoracotomy operations.